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OpenTrials
Completed

NCT Number: NCT07079644

Outcomes of Nivolumab in Combination With Relatlimab in Patients With Advanced Melanoma in the Flatiron Database

The purpose of this study is to investigate the real-world clinical outcomes of individuals that have been diagnosed with advanced melanoma who were treated with Nivolumab in combination with Relatlimab, Nivolumab in combination with Ipilimumab, immuno-oncology monotherapy or BRAF/MEK inhibitors therapy

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Key information

Conditions

Advanced Melanoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bristol Myers Squibb

Princeton, New Jersey, 08540-4715, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants in the advanced melanoma cohort
  • Participants included in the cohort by Flatiron criteria of: cutaneous melanoma with pathologic stages III or IV, either at initial diagnosis or via local or distant recurrence, and at least two clinic encounters evident in the database
  • Participants receiving Nivolumab + Relatlimab between March 18, 2022 and September 30, 2024 or other therapies (Nivolumab + Ipilimumab, immunotherapy monotherapy, BRAF/MEK inhibitors) between March 18, 2022 and November 30, 2024 (or date of the most recent data cut off)
  • Participants ≥18 years old on index date
  • Participants with ≥1 month of medical data after the index date (inclusive), unless patient died within this period

Exclusion criteria

  • Participants with diagnosis of other primary cancers prior to the index date
  • Participants receiving medication in a clinical trial at any time prior to, on or after index date

Treatment and study plan

Nivolumab + Relatlimab

Biological

As per product label

Nivolumab + ipilimumab

Biological

As per product label

Immunotherapy monotherapy

Biological

As per product label

BRAF/MEK inhibitors

Drug

As per product label

Primary outcomes

  1. Demographics

    Time frame: Baseline

  2. Clinical characteristics: Location of metastatic sites

    Time frame: Baseline

  3. Clinical characteristics: Lactate dehydrogenate (LDH) test results

    Time frame: Baseline

  4. Clinical characteristics: BRAF status

    Time frame: Baseline

  5. Clinical characteristics: Eastern Cooperative Oncology Group Performance Status (ECOG PS)

    Time frame: Baseline

  6. Overall survival (OS)

    Time frame: Up to 3-years

  7. Real-world progression-free survival (rwPFS)

    Time frame: Up to 3-years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Real World Outcomes of Nivolumab + Relatlimab in Patients With Advanced Melanoma in the Flatiron Database

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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